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Efficacy of Acupuncture in Refractory Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Acupuncture

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adults aged 18-70 years (either sex);
Fulfilled Rome IV criteria for IBS;
Patients with normal occult blood in stool in recent one month;
The age is above 50, the results of colonoscopy are normal in near year;
Symptoms are present for ≥12 months;
There is an absence of response to a minimum of 6 weeks of dietary intervention or advice;
There is an absence of response to an adequate dose of at least one conventional pharmacological agent tried for a minimum of 6 weeks;
Signed the written informed consent form.

Exclusion Criteria:

Previous colonoscopy, meal barium fluoroscopy, abdominal ultrasound and other examinations found severe intestinal organic lesions (including but not limited to ulcerative colitis, familial multiple intestinal polyps, colorectal cancer patients);
The presence of one or more of the following warning symptoms: unexplained rectal bleeding, a positive faecal occult blood test result; anaemia, abdominal mass, ascites, fever, and emaciation;
The presence of other severe medical conditions, such as cardiovascular disease, endocrine disorders, hepatic dysfunction, renal diseases, and cognitive disorders that can affect the outcome assessment results;
Unconscious, unable to express subjective symptoms of discomfort and clearly diagnosed severe mental disorders;
An unstable psychological state or accompanying psychological disorders (SDS>56);
With pregnancy or lactation;
Accepting acupuncture treatment in the last 3 months;
Difficulties in attending the trial, such as fear of acupuncture.

Sites / Locations

Hospital of Chengdu University of Traditional Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Acupuncture plus usual care

Sham acupuncture plus usual care

Arm Description

Acupuncture will be given on the basis of usual care. A total of 12 sessions of acupuncture will be given over a period of 4 weeks.

Sham acupuncture refers to acupuncture at sham points. Sham acupuncture will be given on the basis of usual care. A total of 12 sessions of sham acupuncture will be given over a period of 4 weeks.

Outcomes

Primary Outcome Measures

The proportion of participants with adequate relief of global IBS symptoms

Adequate relief of global IBS symptoms will be defined as a >50% reduction in the IBS symptom severity scale (IBS-SSS).

Secondary Outcome Measures

IBS symptom severity scale

The IBS symptom severity scale (IBS-SSS) has a total of 500 points. The score ranges from 0 to 500; higher scores indicating more severe symptoms; a score over 300 indicates severe symptoms.

Weekly bowel movements

The total number of bowel movements in a week.

Work and Social Adjustment Scale

The Work and Social Adjustment Scale (WSAS) measures the effect of IBS on ability to work and manage at home, participate in social and private leisure activities and maintain relationships. It has five domains scored 0 (not affected) to 8 (severely affected), with a total possible score of 40.

Irritable Bowel Syndrome Quality of Life Instrument

Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL) is a condition-specific measure for assessing health-related QoL among persons with irritable bowel syndrome. The IBS-QOL had eight subscales. The IBS-QOL and its subscales were both scored on a range of 0-100 with higher scores suggestive of better QOL.

Bristol Stool Form Scale

The Bristol Stool Form Scale is a tool that is used for the assessment of stool consistency. Scores 1-2 indicate constipation, scores 3-5 indicate normal stool; scores 6-7 indicate diarrhea.

Self-Rating Anxiety Scale (SAS)

The SAS is a self rating scale for the assessment of the severity of anxiety.

Self-Rating Depression Scale (SDS)

The SDS is a self rating scale for the assessment of the severity of depression.

Full Information

NCT ID

NCT04276961

First Posted

February 14, 2020

Last Updated

May 6, 2021

Sponsor

Chengdu University of Traditional Chinese Medicine

Collaborators

Beijing University of Chinese Medicine

1. Study Identification

Unique Protocol Identification Number

NCT04276961

Brief Title

Efficacy of Acupuncture in Refractory Irritable Bowel Syndrome

Official Title

Acupuncture in Addition to Usual Care for the Treatment of Refractory Irritable Bowel Syndrome: a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Unknown status

Study Start Date

October 15, 2020 (Actual)

Primary Completion Date

June 1, 2021 (Anticipated)

Study Completion Date

June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chengdu University of Traditional Chinese Medicine

Collaborators

Beijing University of Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The trial aims to examine the efficacy and safety of acupuncture in the treatment of refractory irritable bowel syndrome (IBS). The investigators will include 170 participants to receive acupuncture plus usual care or sham acupuncture plus usual care. Twelve sessions of acupuncture will be delivered to participants over a period of 4 weeks. The primary outcome is defined as proportion of participants with adequate relief of global IBS symptoms at week 8, which is defined as >50% reduction in IBS-SSS scale.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Acupuncture plus usual care

Arm Type

Experimental

Arm Description

Acupuncture will be given on the basis of usual care. A total of 12 sessions of acupuncture will be given over a period of 4 weeks.

Arm Title

Sham acupuncture plus usual care

Arm Type

Sham Comparator

Arm Description

Sham acupuncture refers to acupuncture at sham points. Sham acupuncture will be given on the basis of usual care. A total of 12 sessions of sham acupuncture will be given over a period of 4 weeks.

Intervention Type

Other

Intervention Name(s)

Acupuncture

Intervention Description

Acupuncture will be given for a total of 12 session over 4 weeks. Acupuncture at acupoints Tianshu (ST25), Shangjuxu (ST37), Zusanli (ST36), and Neiguan (PC6) bilaterally will be given.

Primary Outcome Measure Information:

Title

The proportion of participants with adequate relief of global IBS symptoms

Description

Adequate relief of global IBS symptoms will be defined as a >50% reduction in the IBS symptom severity scale (IBS-SSS).

Time Frame

4 weeks after randomization (week 4)

Secondary Outcome Measure Information:

Title

IBS symptom severity scale

Description

The IBS symptom severity scale (IBS-SSS) has a total of 500 points. The score ranges from 0 to 500; higher scores indicating more severe symptoms; a score over 300 indicates severe symptoms.

Time Frame

Baseline (week 0), week 2, 4, 6, 8

Title

Weekly bowel movements

Description

The total number of bowel movements in a week.

Time Frame

Baseline (week 0), week 2, 4, 6, 8

Title

Work and Social Adjustment Scale

Description

Time Frame

Baseline (week 0), week 2, 4, 6, 8

Title

Irritable Bowel Syndrome Quality of Life Instrument

Description

Time Frame

Baseline (week 0), week12, and month12

Title

Bristol Stool Form Scale

Description

The Bristol Stool Form Scale is a tool that is used for the assessment of stool consistency. Scores 1-2 indicate constipation, scores 3-5 indicate normal stool; scores 6-7 indicate diarrhea.

Time Frame

Baseline, weeks 2, 4, 6 and 8.

Title

Self-Rating Anxiety Scale (SAS)

Description

The SAS is a self rating scale for the assessment of the severity of anxiety.

Time Frame

Baseline, weeks 2, 4.

Title

Self-Rating Depression Scale (SDS)

Description

The SDS is a self rating scale for the assessment of the severity of depression.

Time Frame

Baseline, weeks 2, 4.

Other Pre-specified Outcome Measures:

Title

Proportion of participants with adverse events

Description

Side effect of acupuncture or sham acupuncture will be recorded.

Time Frame

Week 4 and 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adults aged 18-70 years (either sex); Fulfilled Rome IV criteria for IBS; Patients with normal occult blood in stool in recent one month; The age is above 50, the results of colonoscopy are normal in near year; Symptoms are present for ≥12 months; There is an absence of response to a minimum of 6 weeks of dietary intervention or advice; There is an absence of response to an adequate dose of at least one conventional pharmacological agent tried for a minimum of 6 weeks; Signed the written informed consent form. Exclusion Criteria: Previous colonoscopy, meal barium fluoroscopy, abdominal ultrasound and other examinations found severe intestinal organic lesions (including but not limited to ulcerative colitis, familial multiple intestinal polyps, colorectal cancer patients); The presence of one or more of the following warning symptoms: unexplained rectal bleeding, a positive faecal occult blood test result; anaemia, abdominal mass, ascites, fever, and emaciation; The presence of other severe medical conditions, such as cardiovascular disease, endocrine disorders, hepatic dysfunction, renal diseases, and cognitive disorders that can affect the outcome assessment results; Unconscious, unable to express subjective symptoms of discomfort and clearly diagnosed severe mental disorders; An unstable psychological state or accompanying psychological disorders (SDS>56); With pregnancy or lactation; Accepting acupuncture treatment in the last 3 months; Difficulties in attending the trial, such as fear of acupuncture.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Min Chen, MD, PhD

Phone

028-87765705

cm@cdutcm.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhi-Gang Li, MD

Organizational Affiliation

Beijing University of Chinese Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital of Chengdu University of Traditional Chinese Medicine

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610075

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hui Zheng

Phone

+862887689918

zhenghui@cdutcm.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Conditional share, the principle investigator will ask for the reasons to use the data.

IPD Sharing Time Frame

After the completing the study for 2 years

Citations:

PubMed Identifier

34518248

Citation

Zhao J, Chen M, Wang X, Ye K, Shi S, Li H, Wang J, Chen X, Ni J, Wei Q, Shi Y, Hu Y, Sun J, Li D, Liu S, Li Z, Zheng H, Yu SG. Efficacy of acupuncture in refractory irritable bowel syndrome: study protocol for a randomised controlled trial. BMJ Open. 2021 Sep 13;11(9):e045655. doi: 10.1136/bmjopen-2020-045655.

Results Reference

derived

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Efficacy of Acupuncture in Refractory Irritable Bowel Syndrome

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